Augmentation in Tx-resistant OCD: an Open Label Trial - Full Text View

Purpose

This study examines the use of Acamprosate (Campral(R)) in the treatment of Obsessive Compulsive Disorder (OCD). The treatment of this condition is difficulty and a large percentage of patients fail to respond to medications and have residual symptoms. Such patients are referred to as having treatment resistant OCD.

Condition	Phase
Obsessive Compulsive Disorder	Phase 4

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Augment in Treatment-resistent Obsessive-compulsive Disorder: an Open-label Trial

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Obsessive-Compulsive Disorder

U.S. FDA Resources

Further study details as provided by Creighton University:

Primary Outcome Measures:

Acamprosate would be efficacious for SSRI resistant OCD symptoms [ Time Frame: Patients will be administered 12 weeks of Acamprosate. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Acamprosate would improve anxiety, depressive symptoms and quality of life in OCD. [ Time Frame: Patients will be administered 12 weeks of Acamprosate ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	April 2006
Study Completion Date:	October 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1

Detailed Description:

A patient will receive study drug for about 12 weeks. Throughout the study, the study doctor, on best medical judgment, may gradually increase or decrease the dose of the study medication. The adjustments will dependent on the subject's response and whether the subject has side effects. Once the subject has completed treatment under this study, the subject may resume standard treatment for his/her obsessive compulsive disorder by their regular doctor.

Eligibility

Ages Eligible for Study:	19 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Psychiatry clinic

Criteria

Inclusion Criteria:

Men and women between 19-55 years of age
have dx of OCD as determined by the structured clinical interview for DSM-IV axis 1 disorders
SSRI resistant patients with OCD
Subjects who are able to comprehend and satisfactorily comply with protocol requirements and have ability to read and write English.
Signed written informed consent prior to entering any study procedures.
Concomitant psychotropic medications permitted only if prescribed at stable dose for at least 1 month before screening visit

Exclusion Criteria:

Patients with concurrent DSM-IV diagnosis of delirium, dementia, amnestic and other cognitive disorders
Patients with concurrent DSM-IV diagnosis of mental retardation
Patients with concurrent DSM-IV diagnosis of lifetime schizophrenia and other psychotic disorders
Patients with concurrent DSM-IV diagnosis of lifetime bipolar disorder
Substance dependence or abuse (excluding nicotine) within 6 months prior to screening visit
Patients with score of less than 16 on Y-BCOS during screening.
Patients with history of intolerance or hypersensitivity to acamprosate.
Patients based on history or mental status exam have significant risk fo committing suicide.
Patients who are homicidal or violent.
Patients with severe renal impairment
Female patients who are pregnant or lactating
Subjects with history of psychosurgery for OCD

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00590642

Locations

United States, Nebraska
Creighton University Department of Psychiatry
Omaha, Nebraska, United States, 68131

Sponsors and Collaborators

Creighton University

Forest Laboratories

Investigators

Principal Investigator:

Sriram Ramaswamy, MD

Creighton University

More Information

Publications:

Hollander E, Greenwald S, Neville D, Johnson J, Hornig CD, Weissman MM. Uncomplicated and comorbid obsessive-compulsive disorder in an epidemiologic sample. Depress Anxiety. 1996-1997;4(3):111-9.

Karno M, Golding JM, Sorenson SB, Burnam MA. The epidemiology of obsessive-compulsive disorder in five US communities. Arch Gen Psychiatry. 1988 Dec;45(12):1094-9.

den Boer JA. Psychopharmacology of comorbid obsessive-compulsive disorder and depression. J Clin Psychiatry. 1997;58 Suppl 8:17-9.

Hollander E. Obsessive-compulsive disorder-related disorders: the role of selective serotonergic reuptake inhibitors. Int Clin Psychopharmacol. 1996 Dec;11 Suppl 5:75-87. Review.

Keuneman RJ, Pokos V, Weerasundera R, Castle DJ. Antipsychotic treatment in obsessive-compulsive disorder: a literature review. Aust N Z J Psychiatry. 2005 May;39(5):336-43. Review.

Saxena S, Rauch SL. Functional neuroimaging and the neuroanatomy of obsessive-compulsive disorder. Psychiatr Clin North Am. 2000 Sep;23(3):563-86. Review.

Moore GJ, MacMaster FP, Stewart C, Rosenberg DR. Case study: caudate glutamatergic changes with paroxetine therapy for pediatric obsessive-compulsive disorder. J Am Acad Child Adolesc Psychiatry. 1998 Jun;37(6):663-7.

Rosenberg DR, MacMaster FP, Keshavan MS, Fitzgerald KD, Stewart CM, Moore GJ. Decrease in caudate glutamatergic concentrations in pediatric obsessive-compulsive disorder patients taking paroxetine. J Am Acad Child Adolesc Psychiatry. 2000 Sep;39(9):1096-103.

Chakrabarty K, Bhattacharyya S, Christopher R, Khanna S. Glutamatergic dysfunction in OCD. Neuropsychopharmacology. 2005 Sep;30(9):1735-40.

Coric V, Taskiran S, Pittenger C, Wasylink S, Mathalon DH, Valentine G, Saksa J, Wu YT, Gueorguieva R, Sanacora G, Malison RT, Krystal JH. Riluzole augmentation in treatment-resistant obsessive-compulsive disorder: an open-label trial. Biol Psychiatry. 2005 Sep 1;58(5):424-8.

Poyurovsky M, Weizman R, Weizman A, Koran L. Memantine for treatment-resistant OCD. Am J Psychiatry. 2005 Nov;162(11):2191-2. No abstract available.

De Witte P, Littleton J, Parot P, Koob G. Neuroprotective and abstinence-promoting effects of acamprosate: elucidating the mechanism of action. CNS Drugs. 2005;19(6):517-37. Review.

Littleton J, Zieglgänsberger W. Pharmacological mechanisms of naltrexone and acamprosate in the prevention of relapse in alcohol dependence. Am J Addict. 2003;12 Suppl 1:S3-11. Review.

Dahchour A, De Witte P. Effects of acamprosate on excitatory amino acids during multiple ethanol withdrawal periods. Alcohol Clin Exp Res. 2003 Mar;27(3):465-70.

Putzke J, Spanagel R, Tölle TR, Zieglgänsberger W. The anti-craving drug acamprosate reduces c-fos expression in rats undergoing ethanol withdrawal. Eur J Pharmacol. 1996 Dec 12;317(1):39-48.

al Qatari M, Khan S, Harris B, Littleton J. Acamprosate is neuroprotective against glutamate-induced excitotoxicity when enhanced by ethanol withdrawal in neocortical cultures of fetal rat brain. Alcohol Clin Exp Res. 2001 Sep;25(9):1276-83.

Goodman WK, Price LH, Rasmussen SA, Mazure C, Fleischmann RL, Hill CL, Heninger GR, Charney DS. The Yale-Brown Obsessive Compulsive Scale. I. Development, use, and reliability. Arch Gen Psychiatry. 1989 Nov;46(11):1006-11.

Responsible Party:	Sriram Ramaswamy, M.D., Creighton University
ClinicalTrials.gov Identifier:	NCT00590642 History of Changes
Other Study ID Numbers:	CMP-MD-14
Study First Received:	December 11, 2007
Last Updated:	November 27, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Creighton University:

obsessive compulsive disorder
OCD
treatment-resistant
SSRI

Additional relevant MeSH terms:

Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders

ClinicalTrials.gov processed this record on June 13, 2013